MAUDE Adverse Event Report: HEART VALVES SANTA ANA HANCOCK; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number HC15025

Device Problem Gradient Increase (1270)

Patient Problems Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 3 years and 9 months post implant of this pulmonary valved conduit in a pediatric patient, it was replaced valve-in-valve with a transcatheter pulmonary valve (tpv).The reasons for replacement were stenosis, a mean pressure gradient of 45 mmhg, and mild to moderate regurgitation.No additional adverse patient effects were reported.

• Brand Name: HANCOCK
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8678250
• MDR Text Key: 147310836
• Report Number: 2025587-2019-01853
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2019
• Device Model Number: HC15025
• Device Catalogue Number: HC15025
• Device Lot Number: B307017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2019
• Date Device Manufactured: 11/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR
• Patient Weight: 73